Replies to post #687738 on NorthWest Biotherapeutics Inc (NWBO)

[manibiotech]

Logistically , chances of pre market or during market hours are much higher as UK is 5 hours ahead of NY. They will likely get notification of approval during UK office hours .

[learningcurve2020]

I know GuruGary is for real because no good boiler room would have his boring drawn out material.

[underpar71]

All I know is that we are at least 130 days post-submission. No info, as usual, from the company on: when validation was, if we were accepted in the 150 day review, or if there has been a RFI. Three important pieces that would give a better idea of when to expect decision from MHRA. If validation was 10 days post-submission and no RFI, then the 150 day decision could come anytime and up until about the end of May. Other than that, it could be several more months with RFI and/or not being evaluated under the 150 day process.

[HappyLibrarian]

Personally while I don't remember which poster said no RFI was requested, it's was someone I respect and who I believed was living somewhere in Europe, so they could be in a position to actually know. Of course it also could be a good, or bad guess, but that's why I'm at 90% and not higher.

I guess by that standard, anyone living in Canada, Mexico, Central America or the United States ‘could be in a position to know’ what the FDA is doing!

Wow.

[FeMike]

Personally while I don't remember which poster said no RFI was requested, it's was someone I respect and who I believed was living somewhere in Europe, so they could be in a position to actually know. Of course it also could be a good, or bad guess, but that's why I'm at 90% and not higher.

In speaking with folks actually involved in these processes (MAA's with the MHRA) I have yet to find someone that has ever seen an MAA not receive a request for information. Literally not a single example.

So, ya know, anything is possible. But it's probably a safe bet to just assume the RFI is a given.